There is a continued need within research and development organisations, particularly in the chemical and biological fields, to be able to identify individual samples undergoing preparation or analysis. In the pharmaceutical industry, these samples generally take the form of clinical, biological or chemical samples. The growing trend towards automation of sample preparation and assay within the pharmaceutical industry to satisfy new drug discovery, evaluation and clinical trial programmes, greatly increase the needs to identify unique samples accurately and rapidly.
Clinical trial studies, such as metabolism and toxicity studies, are used to aid development of potential drug candidates. These studies must comply with Good Laboratory Practice (GLP) and other regulatory requirements to satisfy national authorities where registration of the new drug is sought. In many cases, additional compliance requirements, such as Good Manufacturing Practice (GMP), must also be satisfied.
The processing, storing and handling of sample data, particularly of clinical trials samples, requires careful control to ensure data quality and security. It is now common practice within the pharmaceutical industry to attach textual and/or bar coded labels to clinical trial samples to identify them via a unique bar coded identifier. Whilst the use of bar codes has greatly improved the speed and accuracy of sample identification compared to sample identification based solely on visual text recognition, such processes are still time consuming and prone to errors. Considerable time is required to scan, and often re-scan, individual bar coded samples into databases, prior to any sample preparation or assay. The ‘line of sight’ also imposes restrictions on the speed and accuracy of reading. These restrictions on readability often lead to samples being manually entered into databases, thereby introducing more errors and time delays into the process.
The Applicants have now devised a method for identifying and recording samples which address the aforementioned problems associated with conventional, bar coded techniques. The method involves the attachment of a RFID tag to a sample container, the RFID tag having a memory structure which allows for large amounts of information to be stored thereon. The memory structure can be arranged such that parts of the memory are read-only, other parts are read/write and further parts are encrypted and password protectable. Transfer of information to or from the memory is readily achievable by the use of a reader that is typically remote from the sample container. The use of such readers thus eliminates the ‘line of sight’ requirement described above for barcodes and minimises the need for any manual handling. In further aspects, the reader can be arranged to simultaneously read and write to the memory of multiple RFID tags on multiple sample containers. The invention may be used alone or in combination with existing identification systems, such as barcode and textual identifiers.
A principal advantage of the present invention is the ability to store many types of information in different parts of the memory structure of the RFID tag. The information could, for example, include clinical trial compliance information written to the memory at various time points in the trial process, thereby providing a detailed and readily accessible sample history of the clinical trial sample. The information could also include a unique serial number stored in encrypted form or in a password protectable part of the memory that uniquely identifies the sample container.
U.S. Pat. No. 5,963,136 describes an interactive prescription compliance and life safety system which provides remote and on site verification of procedures related to the health status of a patient, including the taking of medicines. One element of this system is the use of a RFID tag attached to a vial containing a drug prescribed by a medical practitioner.
U.S. Pat. No. 5,771,657 describes an automatic prescription dispensing and packaging system whereby empty prescription bottles are labelled and loaded in assigned locations in a carrier. The carriers are identified by use of a RFID tag and associated reader.